Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

European Pharmaceutical Review

MARCH 8, 2023

After moving to London in 2011, Ekaterina worked in global health and medical philanthropy, focusing on improving outcomes in maternal and child health. At COMPASS, I currently oversee the development of innovative therapies which includes drug development, and innovations more broadly to support drug delivery, such as digital innovation.

Leads 52

Leads Pharma Food and Drug Administration Medicine 52

European Pharmaceutical Review

JULY 13, 2023

A new therapeutic antibody class, bispecific antibodies, was engineered to build on the classic antibody design and bind to two different proteins, demonstrating how incremental changes in protein design can lead to entirely new therapies. 3 The CARs recognise and bind to proteins on the surface of cancer cells, effectively killing them.

Engineering 98

Engineering Food and Drug Administration Patients Safety 98

European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year.

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Transportation Manufacturing 98

European Pharmaceutical Review

MARCH 7, 2024

Last month, construction began on Europe’s first industrial-scale facility dedicated to the production of lead-212 based radioligand therapies. Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024.

Manufacturing 52

Manufacturing Food and Drug Administration Marketing Management 52